Innovative Solutions to Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Difference of Cytokine response - ECMO patients
研究概览
简要总结
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
详细描述
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure.
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure.
Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients with ECMO:
- •Hemodynamic support with vasopressors
- •Procalcitonin level ≥ 1 ng/ml
- •Invasive hemodynamic monitoring
- •Written informed content
- •ICU patients with the septic shock of medical origin:
- •Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg)
- •Hemodynamic support with vasopressors
- •Procalcitonin level ≥ 1 ng/ml
- •Invasive hemodynamic monitoring
- •Written informed content
排除标准
- •ICU patients with ECMO:
- •age < 18 years
- •acute liver or kidney failure straight before transplantation
- •the patient declines to participate in the study
- •ICU patients with the septic shock of medical origin:
- •Patients under 18 years
- •Pregnancy (bHCG test positivity)
- •Surgical intervention in context with the septic insult New York Heart Association IV heart failure
- •Acute coronary syndrome
- •Acute hematological malignancies
- •Immunosuppression, systemic steroid therapy (>10mg prednisolone/day)
- •Human immunodeficiency virus infection (HIV) and active AIDS
- •Patients with donated organs
- •Thrombocytopenia (<20.000/ml)
- •More than 10%-of body surface area with third-degree burn
研究组 & 干预措施
Cytokine adsorber patients on ECMO
Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)
干预措施: Cytokine adsorber filter (Device)
Cytokine adsorber patients with sepsis
Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)
干预措施: Cytokine adsorber filter (Device)
Extracorporeal hemoperfusion cartridge patients on ECMO
Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)
干预措施: Extracorporeal hemoperfusion cartridge (Device)
Extracorporeal hemoperfusion cartridge patients with sepsis
Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)
干预措施: Extracorporeal hemoperfusion cartridge (Device)
Control (subgroups)1
No filter will be installed into the ECMO in this study group (15 patients)
Control (subgroups) 2
No filter will be installed into the patient with sepsis (15 patients)
结局指标
主要结局
Difference of Cytokine response - ECMO patients
时间窗: 6-24 hours
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) before initiation of ECMO, 2 hours after initiation ECMO support, at explantation of ECMO support, 6-12-24 hours after explantation of ECMO support.
Difference of Cytokine response - Patients with septic shock
时间窗: 24-48 hours of septic shock
Level of procalcitonin, Level of C-reactive protein, Level of interleukin-1, Level of interleukin-6, Level of interleukin-8, Level of interleukin-10, Level of Tumor Necrosis Factor- αinterleukin-8, interleukin-10, Tumor Necrosis Factor- α at 24, 48 hours.
次要结局
- adverse event of special interest: bleeding complications - ECMO patients(30 days)
- Ventilator free days (VFD) - ECMO patients(30 days)
- Difference of serum interleukin-6 level - Patients with septic shock(48, 72 hours)
- Time to extubation from ventilation and explantation from ECMO - ECMO patients(30 days)
- Difference of d-dimers - ECMO patients(24, 48, 72 hours)
- serious adverse device effects - ECMO patients(30 days)
- Difference of Serum lactate - ECMO patients(24, 48, 72 hours)
- SOFA-Score - ECMO patients(24, 48, 72 hours)
- adverse event of special interest: air in the ECMO system - ECMO patients(30 days)
- Inflammatory reaction - Patients with septic shock(6-24 hours)
- Difference of serum interleukin-10 level - Patients with septic shock(24, 48, 72 hours)
- adverse event of special interest: blood-clotting in the ECMO system(30 days)
- Difference of serum procalcitonin level - Patients with septic shock(24, 48, 72 hours)
- Difference of serum interleukin-1β level - Patients with septic shock(24, 48, 72 hours)
研究者
Timur Lesbekov
Head of the Department of Cardiac Surgery
National Research Center for Cardiac Surgery, Kazakhstan